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Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)

Sponsor
NYU Langone Health (Other)
Overall Status
Terminated
CT.gov ID
NCT02695602
Collaborator
(none)
2
Enrollment
1
Location
2
Arms
15.2
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, patient blinded, randomized, clinical trial enrolling patients with symptoms and signs of nasal obstruction related to enlarged inferior turbinates. The purpose of this study is to compare two different surgical methods, both of which are already in common use, for the treatment of nasal obstruction in patients with inferior turbinate hypertrophy.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Microdebrider-Assisted Inferior Turbinoplasty (MAIT)
  • Procedure: Submucous Resection with non powered instrument
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)
Actual Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
May 9, 2017
Actual Study Completion Date :
May 9, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Microdebrider-Assisted Inferior Turbinoplasty (MAIT)

Turbinoplasty using microdebrider turbinate blade (2.9mm inferior turbinate blade, Medtronic, 5000 Hz)

Procedure: Microdebrider-Assisted Inferior Turbinoplasty (MAIT)
Other Names:
  • Medtronic

    		•
    Experimental: Submucous Resection (SMR)

    Turbinoplasty using non-powered instruments

    Procedure: Submucous Resection with non powered instrument
    Other Names:
  • Jansen-Middleton or straight through cut

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Nasal Obstruction Symptom Evaluation (NOSE) Score in MAIT vs SMR treated patients [3 years post-operative]

    2. Measure of pain on the Visual Analog Scale [3 years post-operative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Symptoms of chronic nasal obstruction with an exam finding of turbinate hypertrophy, with or without septal deviation will be eligible for the study.

    • Failed medical treatment

    • Have failed medical treatment for at least 1 month, and will be offered surgery

    • Patients having Septoplasty at the same time as their turbinate reduction surgery.

    Exclusion Criteria:

    • Patients who have had previous turbinate reduction surgery will be excluded.

    • Patients that have nasal polyps, chronic rhinosinusitis, adenoid hypertrophy, nasal tumors, or any other exam finding that would explain their symptoms of nasal obstruction other than enlarged inferior turbinates with or without septal deviation will be excluded.

    • Patients who are diagnosed with purely bony inferior turbinate hypertrophy as discussed below.

    • Patients on hormone or anticoagulation therapy and those who have a history of head and neck radiation therapy will be excluded.

    • All study candidates will be assessed for external nasal valve collapse via the modified Cottle maneuver, and will be excluded if they exhibit significant external or internal nasal valve collapse as their primary cause of their nasal obstruction.

    • All patients will complete the Visual Analog Scale (VAS) on nasal obstruction before and after decongestion at their preoperative visit. Patients that fail to report a score less than 5 after decongestion are likely to have bony rather than soft tissue hypertrophy. In these patients MAIT is unlikely to be an adequate surgical option, and they would derive a greater amount of benefit from SMR. Therefore these patients will be excluded from the study, and offered only SMR.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York University School of Medicine New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health

    Investigators

    • Principal Investigator: Seth Lieberman, New York University Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT02695602
    Other Study ID Numbers:
    • 15-01264
    First Posted:
    Mar 1, 2016
    Last Update Posted:
    May 10, 2017
    Last Verified:
    May 1, 2017
    Additional relevant MeSH terms:
    Nasal Obstruction

    Study Results

    No Results Posted as of May 10, 2017